Delafloxacin Medicine 12 June 2019 Extended indication Community acquired pneumonia Therapeutic value No judgement yet Total cost Registration phase Clinical trials Product Active substance Delafloxacin Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Bacterial infections Extended indication Community acquired pneumonia Current proprietary name Already available biosimilars / generics Proprietary name Quofenix Manufacturer Menarini Benelux Portfolio holder Mechanism of action Antibiotic Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Unknown Centre of expertise Additional remarks Ook beschikbaar als tablet. DNA gyrase inhibitor; DNA topoisomerase IV inhibitor; Protein 50S ribosomal subunit inhibitor. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indiening voor deze indicatie bij de FDA verwacht in H1 2019. Therapeutic value Current treatment options Afhankelijk van de diagnose: amoxicilline, doxycycline, azitromycine, claritromycine, cotrimoxazol, levofloxacine, moxifloxacine. Therapeutic value No judgement yet This assessment does not indicate any potential inclusion in the package. Substantiation Geen meerwaarde tov levofloxacin en moxifloxacin. Duration of treatment Frequency of administration 2 times a day Dosage per administration 300 - 450 mg References Farmcotherapeutisch Kompas; NCT02679573 Additional remarks 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Aleva en Boersma. Ned Tijdschr Geneeskd. 2005;149:2501-7; Verheij en Boudry, Ge-Bu, Nr 7, 2006 (40), Pagina 73-79 Additional remarks De incidentie van CAP in de huisartsenpraktijk is 5-8 per 1.000 patiënten per jaar (in totaal 85.000-136.000). Ongeveer één op de tien patiënten wordt in een ziekenhuis opgenomen (8.500-13.600). Het totaal aantal patiënten dat in aanmerking zal komen voor deze behandeling is verwaarloosbaar in Nederland bij CAP. Expected cost per patient per year Cost References GoodRx.com Additional remarks 20 tabletten van Baxdela 450mg betreft $1,350.00. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions References Additional remarks Other information Additional remarks